BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3092942 · Received May 3, 2013

    Report

    Report Number
    2032227-2013-01644
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    March 14, 2013
    Report Date
    April 8, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS UNABLE TO PRIME DURING THE PRIME TEST DUE TO A FAULTY FORCE SENSOR. UNABLE TO PERFORM THE BASIC OCCLUSION, OCCLUSION AND EXCESSIVE NO DELIVERY TESTS DUE TO THE PRIME ANOMALY. HOWEVER, THE INSULIN PUMP PASSED THE DISPLACEMENT AND PRIME TESTS. NO MOTOR ERROR ALARMS NOTED. THE INSULIN PUMP PASSED THE MOTOR TEST.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED WITH BLOOD GLUCOSE LEVELS GREATER THAN 600 MG/DL. THE MOTHER STATED THAT THE CUSTOMER HAD BACTERIAL PNEUMONIA AND SARCOIDOSIS AS WELL. THE CUSTOMER HAD BEEN IN THE HOSPITAL FOR TEN DAYS, AND WAS TAKEN OFF THE INSULIN PUMP, BUT HAD TO BE PUT BACK ON IT BECAUSE MANUAL INJECTIONS ALONE WERE NOT WORKING FOR HIM. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. FOUND MULTIPLE NO DELIVERY AND MOTOR ERROR ALARMS IN THE ALARM HISTORY. THE CALLER DIDN'T HAVE A TUBING CLAMP TO CONDUCT THE HIGH PRESSURE TEST. ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED DUE TO THE REPEATED ALARMS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195239 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization